Application 211843

Type: NDA
Sponsor: MISSION PHARMACAL CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	THIOLA EC	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	100MG	Yes	No
002	THIOLA EC	TIOPRONIN	TABLET, DELAYED RELEASE;ORAL	300MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N211843-001	THIOLA EC	TIOPRONIN	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28
N211843-002	THIOLA EC	TIOPRONIN	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N211843-001	AB
N211843-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211843-001	11458104	2038-11-14	U-3441		2022-10-06
N211843-002	11458104	2038-11-14	U-3441		2022-10-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211843-001	ODE*	2026-06-28
N211843-002	ODE*	2026-06-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2019-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2019-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211843-001	THIOLA EC	100MG	TABLET, DELAYED RELEASE / ORAL		RLD	2019-06-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211843-002	THIOLA EC	300MG	TABLET, DELAYED RELEASE / ORAL		RLD, RS	2019-06-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	AB	1	`9b2671bbb829…`
2023-05-13 08:27 UTC	2023-05	N211843-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211843-002	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211843-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-001	11458104	2038-11-14	U-3441	2022-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	11458104	2038-11-14	U-3441	2022-10-06	`9b2671bbb829…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211843-001	ODE*	2026-06-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211843-002	ODE*	2026-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211843-001	ODE*	2026-06-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211843-002	ODE*	2026-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-001	ODE*	2026-06-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211843-002	ODE*	2026-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211843-001	ODE*	2026-06-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211843-002	ODE*	2026-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-001	ODE*	2026-06-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211843-002	ODE*	2026-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-001	ODE*	2026-06-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211843-002	ODE*	2026-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-001	ODE*	2026-06-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211843-002	ODE*	2026-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-001	ODE*	2026-06-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211843-002	ODE*	2026-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-001	ODE*	2026-06-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211843-002	ODE*	2026-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-001	ODE*	2026-06-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211843-002	ODE*	2026-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211843-001	ODE*	2026-06-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211843-002	ODE*	2026-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-001	ODE*	2026-06-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211843-002	ODE*	2026-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-001	ODE*	2026-06-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211843-002	ODE*	2026-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-001	ODE*	2026-06-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211843-002	ODE*	2026-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211843-001	ODE*	2026-06-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211843-002	ODE*	2026-06-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-001	ODE*	2026-06-28	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211843-002	ODE*	2026-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211843-001	ODE*	2026-06-28	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211843-002	ODE*	2026-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211843-001	ODE*	2026-06-28	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211843-002	ODE*	2026-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-001	ODE*	2026-06-28	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211843-002	ODE*	2026-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-001	ODE*	2026-06-28	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211843-002	ODE*	2026-06-28	`9b2671bbb829…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Thiola EC	TIOPRONIN	Mission Pharmacal Company	20298a52-a194-a161-8632-d84b6f26e23c	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843 ndc (product): 0178-0902 ndc (product): 0178-0901
Tiopronin	TIOPRONIN	BioComp Pharma, Inc.	1f2eb1d6-faa6-e352-e063-6294a90a7fb5	2025-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211843 application number: NDA211843

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0178-0901	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0901	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0902	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current
0178-0902	Thiola EC	tiopronin	Mission Pharmacal Company	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66731	SUPPL	2021-03-10
66677	SUPPL	2021-03-09
61493	ORIG	2020-01-02
59222	ORIG	2019-07-02
59200	ORIG	2019-07-01